Microbiologist - 24990

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Microbiologist for a 9 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

Position Description (Principle Duties and Responsibilities)
 As a Microbiologist you will apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments.

• Actively support new product development activities. 
• Participate in the development and improvement of the manufacturing processes for existing and new products. 
• May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ). 
• Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects. 
• Support product transfers to other plants/facilities. 
• Review/approve nonconforming material and system documentation. 
• Review/approve product and process change control documentation and specifications. 
• Act as mentor to others.

Qualifications: 

• Bachelor's Degree in Biology, Microbiology, or a closely related life science. 
• 1-3 years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience. 
• Must understand the fundamentals of one of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat. 
• Prefer demonstrated competency in advanced testing technologies. 
• Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures. 
• Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives. 
• Ability to effectively work cross-functionally with Product Development, Operations and Marketing. 
• Demonstrated ability to manage workload. 
• Demonstrated communication skills across different organizational levels. 
• Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met. 
• Demonstrated ability to technically mentor associate engineers and scientists.